Noninvasive Ventilation Therapy for the Treatment of Pleural Effusion in Patients With Heart Failure

NCT03189654 | Completed

• 1 other identifier: HDZNRW-KA_010_TB
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

There are no investigations so far whether an application of positive pressure during non-invasive ventilation might be a therapeutic option for transudative pleural effusion in patients with heart failure. In view of the pathophysiological process with pleural effusion resulting from an increase in intravascular hydrostatic pressure, non-invasive ventilation might provide an improvement. The aim of the present study is to investigate whether an additional non-invasive ventilation therapy leads to an improved suppression of pleural effusion in heart failure patients.

Conditions

Pleural Effusion; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Amount of pleural effusion

  5 days

Secondary Outcomes (3)

• nt-Pro-BNP

  5 days

• Cardiac output

  5 days

• NYHA class

  5 days

Study Arms (2)

Treatment group

Non-invasive ventilation after pleurocentesis

Device: Non-invasive ventilation

Control group

Oxygen Administration via nasal tube

Interventions

Non-invasive ventilation DEVICE

Non-invasive Ventilation for a Minimum of 8 h per day after pleurocentesis

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with decompensated heart failure and pleural effusion

You may qualify if:

• Patients admitted to our hospital on a routine or emergency basis
• Patients with heart failure according to the current ESC guidelines and chronic pleural effusion with clinical indication for pleurocentesis
• Non-invasively determined cardiac index of \< 2.5 l/min/m²
• BNP \> 300 pg/ml
• Transudative pleural effusion according to Light criteria
• Effective pleurocentesis with residual effusion on the side affected of \< 500 ml
• Tolerance of non-invasive ventilation without subjective or objective hemodynamic impairment as verified during a test ventilation
• No change in drug or other therapy for the duration of the study (5 days)

You may not qualify if:

• Psychological or neurological concomitant disease making an informed consent impossible
• Pregnancy
• Pneumothorax or pneumomediastinum
• Pathologically low blood pressure, particularly associated with intravascular volume depletion
• Liquor discharge, recent head surgery or trauma
• Severe bullous lung disease
• Dehydration
• Current ventilation therapy
• Bilateral pleural effusion \> 500 ml at the time of enrolment
• Exudative pleural effusion

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead
• ResMed GmbH & Co KG: collaborator

Study Sites (1)

Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum

Bad Oeynhausen, 32545, Germany

Location

MeSH Terms

Conditions

Pleural Effusion; Heart Failure

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Thomas Bitter, MD

  Heart and Diabetes Center North Rhine-Westphalia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 16, 2017
• Study Start: July 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: March 12, 2020
• Last Updated: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)